JP5709747B2 - Penetration member with direct visualization - Google Patents

Description

(Cross-reference of related applications)
This application claims the benefit of the priority of 35 USC 119 (e) of US Provisional Patent Application No. 61 / 084,202 (filed 28th of May 2008), the disclosure of which is The entirety of which is incorporated herein by reference.

(Background of the Invention)
Intervertebral disc injuries are generally treated with bed rest, physical therapy, activity changes, and analgesics for a substantial treatment period. There are many therapies that attempt to repair a damaged disc and avoid surgical removal of the damaged disc. For example, disc decompression is a procedure used to reduce and reduce pressure on the annulus fibrosus and nerves by removing or constricting the nucleus pulposus. Less invasive microscopic lumbar discectomy and automated percutaneous lumbar discectomy remove the nucleus pulposus of the disc by aspiration through a needle inserted laterally into the annulus. Another procedure involves implanting a disc augmentation device to treat, delay or prevent degeneration of the disc. Augmentation includes (1) enhancement of the annulus fibrosus, including repair of herniated disc, support of damaged annulus fibrosus, and closure of the annulus fibrosus, and (2) enhancement of the nucleus pulposus, including the addition of substances to the nucleus pulposus. Mean both. Many conventional treatment devices and techniques, including open approaches, involve muscle incisions or percutaneous procedures to puncture parts of the disc under fluoroscopic guidance, but do not use direct visualization . Some treatments also seek to reduce discogenic pain by injecting drugs into the suspected damaged area or by dissolving adhesions. However, these devices also offer little in the sense of touch for the surgeon or that the surgeon can operate without damaging the surrounding tissue. In general, these conventional systems do not have any kind of real-time on-board visualization capability because they rely on external visualization to reach the disc.

  Drug therapy and physical therapy can be considered as primary solutions for spinal related diseases. However, these therapies cannot fully address the underlying pathology. In contrast, current surgical solutions such as laminectomy, which removes the vertebral arch (a thin bone plate covering the spinal canal), allows for the exposure and access of nerve roots, and the underlying pathology Corresponding to From there, bone fragments that collide with the nerve can be removed. Screws, interbody spacers, and fixation plates may be used to fuse or stabilize the spine after laminectomy. However, these surgical procedures are very invasive and often require extensive muscle incisions to achieve proper surgical exposure, so long-term surgery under general anesthesia The result is an extended time and recovery period. To improve surgical access, bone tissue is sometimes removed, but at the same time it may increase the risk of damage to nearby neurovascular structures. Other surgical methods have been attempted, such as laminectomy focused on removing only certain portions or smaller pieces of the lamine.

  In addition, accurately diagnosing back pain is often more difficult than many expect, and may involve a thorough combination of patient history and physical examination, and a series of diagnostic tests. The major problem is the complexity of the various components of the spine and the wide range of physical symptoms experienced by individual patients. The epidural space also contains various elements such as fat, connective tissue, lymphatic vessels, arteries, veins, blood, and spinal nerve roots. These anatomical structures tend to collapse around any instrument or device inserted therein, making it difficult to treat or diagnose conditions within the epidural region. This reduces visibility within the epidural space and can cause inadvertent damage to the nerve root when the device is inserted. Also, the insertion of the visualization device can result in obstructing or reducing the viewing ability. Thus, many anatomical elements within the epidural space may limit the ability to insert, move, and view any access, visualization, diagnostic, or treatment device that is inserted into the epidural space There is.

Systems and methods for accessing the spine include tissue penetrating members with direct visualization capabilities that can be used to form an access pathway to a target treatment site. The direct visualization capabilities that can be provided by optical fiber illumination and imaging components may be used to visualize tissue as the access path is formed by the tissue penetrating member. Tissue penetrating members include trocars, catheters, and cannulas having sharp tips with integrated fiber optic components and / or channels that can be inserted into a fiberscope or miniscope. An opening and / or transparent material is provided to allow imaging of tissue around the distal end of the tissue penetrating member.
The present invention also provides, for example:
(Item 1)
A method for accessing a patient's epidural space, comprising:
Penetrating intact body tissue using a first flexible fiberscope, wherein the first flexible fiberscope is removably located within a longitudinal lumen of a rigid tubular member; The rigid annular member has a distal penetrating tip and at least one viewing opening located around the distal penetrating tip;
Forming a tissue pathway with the distal penetrating tip through the intact body tissue and toward the patient's epidural space;
Visualizing the tissue path using the first flexible fiberscope while forming at least a portion of the tissue path;
Removing the flexible fiberscope from the rigid tubular member;
Passing and pulling the dilator over the rigid tubular member;
Inserting an introducer over the rigid tubular member;
Removing the rigid tubular member from the introducer;
Inserting a second flexible fiberscope into a steerable multi-lumen cannula;
Inserting the steerable multi-lumen cannula through the introducer;
Using the second flexible fiberscope to visualize the epidural space;
Including a method.
(Item 2)
The method according to item 1, wherein the first flexible fiberscope and the second flexible fiberscope are the same fiberscope.
(Item 3)
The item of claim 1, wherein inserting the second flexible fiberscope into the steerable multi-lumen cannula is performed prior to inserting the steerable multi-lumen cannula through the introducer. Method.
(Item 4)
The method of claim 1, further comprising rotating the first flexible fiberscope within the lumen of the rigid tubular member.
(Item 5)
The method of item 1, further comprising adjusting the formation of the pathway by reorienting the distal penetrating tip toward the spinal region.
(Item 6)
The method of claim 1, further comprising: inserting the steerable multi-lumen cannula through the introducer while visualizing the tissue path using the second flexible fiberscope.
(Item 7)
Visualizing the tissue path using the second flexible fiberscope includes visualizing the tissue path through the introducer wall, wherein at least a portion of the wall is optically transparent. Item 7. The method according to Item 6, which comprises
(Item 8)
The method of item 1, further comprising inserting the first flexible fiberscope into the rigid tubular member.
(Item 9)
Visualizing the tissue path using the first flexible fiberscope includes visualizing the tissue path through an optically transparent structure located in a viewing opening. The method described.
(Item 10)
Placing the distal penetrating tip of the rigid cannula member in a posterior lateral position of the patient laterally from about 8 cm to about 20 cm of the patient's mid-sagittal plane;
Orienting the rigid cannula member at an angle of about 20 degrees to about 50 degrees with respect to the median sagittal plane;
The method according to Item 1, further comprising:
(Item 11)
A method for accessing a patient's body area, comprising:
Puncturing the patient's unpunctured body tissue using a piercing member comprising an illumination assembly and a direct visualization assembly;
Forming a tissue path through the unpunctured body tissue toward the target body site;
Visualizing the tissue pathway using the direct visualization assembly while at least a portion of the tissue pathway is formed through the unpunctured body tissue;
Including a method.
(Item 12)
12. The method of item 11, wherein the unpunctured body tissue is lateral from about 8 cm to about 20 cm of the posterior spinous process of the vertebra.
(Item 13)
12. The method of item 11, further comprising orienting the piercing member at an angle of about 20 degrees to about 50 degrees relative to the midsagittal plane of the patient.
(Item 14)
Item 12. The method according to Item 11, wherein the puncture member is a puncture member with a gradient.
(Item 15)
Item 12. The method according to Item 11, wherein the tissue path passes through at least the sacrospinous, lumbar, and psoas major.
(Item 16)
Item 12. The method according to Item 11, wherein the tissue route passes between at least the sacrospinous, lumbar, and psoas major muscles between the gastrocnemius and thoracolumbar fascia.
(Item 17)
12. The method of item 11, further comprising actuating the steering control of the piercing member to form a non-linear tissue path toward the spine.
(Item 18)
12. The method of item 11, further comprising flowing a fluid through the piercing member before reaching the target body part.
(Item 19)
12. The method of item 11, further comprising confirming the position of the tissue penetrating distal tip by X-ray examination.
(Item 20)
12. The method of item 11, further comprising puncturing through the longest muscle of the patient.
(Item 21)
12. The method of item 11, further comprising puncturing through the patient's multifidus muscle.
(Item 22)
12. The method of item 11, further comprising forming a tissue pathway between the longest muscle of the patient and the adjacent multifidus.
(Item 23)
Removing the illumination assembly and the direct visualization assembly from the piercing member;
Passing the first guide element through the patient's body using the piercing member;
Removing the piercing member while maintaining the first guide element in the patient's body;
The method according to item 11, further comprising:
(Item 24)
In item 23, removing the illumination assembly and the direct visualization assembly from the piercing member includes removing a fiberscope in which the illumination assembly and the direct visualization assembly are integrally formed. The method described.
(Item 25)
Item 12. The method according to Item 11, wherein the target body part is a blood vessel.
(Item 26)
Item 12. The method according to Item 11, wherein the target body part is the epidural space of the spine.
(Item 27)
12. The method according to item 11, wherein the target body part is selected from the group consisting of a breast mass, liver mass, pericardial sac, kidney mass, lung nodule, lymph node, ascites collection, and pleural effusion collection.
(Item 28)
24. The method of item 23, wherein using the puncture member to pass the first guide element through the patient includes inserting a guide wire into the patient through the puncture member.
(Item 29)
Item 23. further comprising passing a second guide element through the patient using the first guide element and removing the first guide element from the second guide element. The method described.
(Item 30)
Inserting the direct visualization assembly into a lumen member;
Inserting the lumen member into the patient;
The method of item 24, further comprising:
(Item 31)
A system for performing an access procedure,
A miniscope,
A video connector located around the proximal end;
A lens located around the distal end;
A flexible axial section comprising at least one illumination optical fiber and at least one viewing optical fiber, having a longitudinal length of at least about 3 inches and an average axial cross-sectional area of less than about 1.2 mm ² ;
With a miniscope,
An elongated puncture member,
A distal penetrating tip;
A miniscope receiving opening;
An axial section located between the distal penetrating tip and the miniscope receiving opening, the axial section comprising a miniscope lumen in communication with the proximal miniscope receiving opening; An axial section having a longitudinal length of about 3 inches and an average axial lumen cross-sectional area of less than about 1.3 mm ² and comprising at least one distal viewing window;
A puncture member comprising
Including the system.
(Item 32)
32. The system of item 31, wherein the miniscope is pre-inserted into the elongate piercing member.
(Item 33)
32. A system according to item 31, wherein the distal penetrating tip comprises a conical configuration.
(Item 34)
32. The system of item 31, wherein the distal penetrating tip comprises at least one cutting blade.
(Item 35)
32. A system according to item 31, wherein the distal penetrating tip comprises a flat blade structure.
(Item 36)
32. The system of item 31, wherein the at least one viewing window comprises a viewing opening.
(Item 37)
32. The system of item 31, wherein the at least one viewing window comprises an optically transparent material.
(Item 38)
32. The system of item 31, wherein the distal penetrating tip comprises an optically transparent material.
(Item 39)
32. The system of item 31, wherein the axial segment of the elongate piercing member is a multi-lumen axial segment.
(Item 40)
40. The system of item 39, wherein the multi-lumen axis comprises at least one fluid lumen.
(Item 41)
40. The system of item 39, wherein the multi-lumen shaft comprises an expandable member connected to the multi-lumen shaft.
(Item 42)
42. The system of item 41, wherein the expandable member comprises a balloon member.
(Item 43)
43. The system of claim 42, wherein the multi-lumen shaft further comprises a balloon inflation lumen.
(Item 44)
32. The system of item 31, wherein at least one viewing window is located at a distal end of the miniscope lumen.
(Item 45)
32. The system of item 31, wherein at least one viewing window is located on a side wall of the miniscope lumen.
(Item 46)
32. A system according to item 31, wherein the elongate piercing member comprises at least two viewing windows.
(Item 47)
47. A system according to item 46, wherein at least two viewing windows are disposed continuously along the longitudinal length of the miniscope lumen.
(Item 48)
47. A system according to item 46, wherein at least two viewing windows are successively arranged in parallel along the longitudinal length of the miniscope lumen.
(Item 49)
32. The system of item 31, wherein the elongate piercing member further comprises a flexible compartment.
(Item 50)
50. The system of item 49, wherein the elongate piercing member further comprises a steering assembly configured to bend the flexible compartment.

The invention is best understood by reading the following detailed description in conjunction with the accompanying drawings. It is emphasized that, according to common practice, the various features of the drawings are not necessarily drawn to scale. Conversely, the dimensions of the various features may be arbitrarily expanded or reduced for clarity. The drawings include the following figures.
1A and 1B are a perspective view and a side elevation view of a fiber optic scope. 2A and 2B are upper and side elevational views of a tubular penetrating member including an inserted fiber optic scope, and FIG. 2C is a cut-away view of the tubular penetrating member of FIG. 2B. 3 to 5 are views showing various other embodiments of the tubular penetrating member. 3 to 5 are views showing various other embodiments of the tubular penetrating member. 3 to 5 are views showing various other embodiments of the tubular penetrating member. 6A and 6B are a side elevation view and a top elevation view of a tubular penetrating member comprising a blade. 7A and 7B are longitudinal cross-sectional views of a multi-lumen penetrating member including an optional balloon in an inflated state and an uninflated state, respectively. FIG. 8 is a longitudinal sectional view of a penetrating member including a transparent visual balloon. FIG. 9 is a side elevation view of a penetrating member including a transparent viewing balloon and a transparent axial section. 10A is a perspective view of a penetrating member including a balloon, FIG. 10B is a detailed view of the distal end of the penetrating member of FIG. 10A, and FIG. 10C is the penetrating portion of FIG. 10A with a portion of the housing removed. It is a cutaway view of a member. 10A is a perspective view of a penetrating member including a balloon, FIG. 10B is a detailed view of the distal end of the penetrating member of FIG. 10A, and FIG. 10C is the penetrating portion of FIG. 10A with a portion of the housing removed. It is a cutaway view of a member. 10A is a perspective view of a penetrating member including a balloon, FIG. 10B is a detailed view of the distal end of the penetrating member of FIG. 10A, and FIG. 10C is the penetrating portion of FIG. 10A with a portion of the housing removed. It is a cutaway view of a member. FIG. 11 is a schematic perspective view of a portion of the lumbar spine. FIG. 12 is a schematic upper elevational view of the lumbar spine. FIG. 13 is a schematic side elevational view of the lumbar spine. 14A and 14B are schematic side and upper elevation views of a posterior spine access procedure. 15A and 15B are schematic side and upper elevation views of a posterior lateral spine access procedure. FIG. 16 is a schematic cross-sectional view of a vascular access procedure.

  In order to reduce bone damage while maintaining bone strength, minimally invasive spine surgery has been used to avoid resection of existing bone and / or incision of surrounding existing tissue. Existing minimally invasive spinal access procedures have been performed using both fluoroscopic guidance and endoscopic visualization. Existing spinal endoscopy systems, once accessed, provide direct visual capabilities for viewing the treatment area of the spine or other areas of the body, but these systems are iatrogenic to nerves and blood vessels Often accompanied by risk of damage or difficulty in localizing the target site. Similar risks and difficulties include, but are not limited to, numerous other, including, for example, placement of subclavian and internal jugular vein catheters, renal biopsy, liver biopsy, puncture, pleuropuncture, and femoral artery Accompanying minimally invasive and limited access procedures.

  The source of these risks may be in the procedure used to reach the treatment site. Before the actual diagnostic or interventional treatment can be started, the treatment site must be accessed. This is typically done using a guide wire, needle, or trocar with a sharp tip, under fluoroscopy or x-ray imaging, without endoscopic visualization. Detection of bone and other calcified structures using fluoroscopy is relatively simple, but detection of soft tissue structures using fluoroscopy is still a problem, even with contrast agent injections There is. Thus, during fluoroscopic procedures, soft tissue structures such as nerves and blood vessels in close proximity to the treatment site are at significant risk of accidental damage. Overuse of fluoroscopy and other indirect imaging systems can also expose both patients and healthcare workers to long-term risks associated with ionizing radiation.

  However, further safety improvements can be achieved by providing direct or local visualization at the initial access stage of the invasive procedure rather than after reaching the target site. This may be a guide wire, cannula, or trocar having a penetrating tip and a direct visualization system, for example to view body tissue as it cuts or punctures intact tissue so that the penetrating tip reaches the target site Etc. may be performed by providing a device such as The target site may be, for example, a breast mass, a solid tissue such as a body structure wall or lumen, or a potential or actual space of a body cavity. By visualizing the body tissue while achieving access to the target site, the access device may be reoriented once a particular structure or tissue is visualized.

  1A and 1B illustrate one embodiment of a fiber optic scope 2 that can be inserted into a patient's body for optical visualization of tissue and structure. The scope 2 comprises a proximal housing 4 that is used to receive a visual image from the distal end 6 of the scope 2 and optionally transmit illumination to the distal end 6. In this particular embodiment, the proximal housing 4 couples the scope 2 to a video monitor and / or illumination system, with an eyepiece 8 that can be used to view a light image transmitted from the distal end 6 of the scope 2. And a connector 10 that can be used. In other examples, the scope may have an eyepiece only, a monitor / lighting connection only, or separate connections for monitoring and lighting. The proximal housing 4 may be connected to a shaft assembly 12 that includes a proximal shaft section 14, a distal shaft section 16, and an optional handle 18. There may or may not be a visual depiction between the proximal and distal shaft sections, and in some embodiments, the proximal and distal shaft sections are of a continuous shaft body. The opposite ends may be used. In the illustrated shaft assembly 12, in some embodiments, the distal shaft section 16 is about 0.5 mm to about 1.5 mm or more, sometimes about 0.7 mm to about 1.2 mm, and in other cases about 0.1 mm. It can have a diameter or average abscissa dimension in the range of 8 mm to about 1 mm. The length of the distal shaft section 16 may range from about 30 mm to about 1 meter or more, sometimes from about 200 mm to about 600 mm, and in other cases from about 300 mm to about 500 mm. Proximal housing 4 and / or handle 18 can have moldings, gripping materials, and / or surface features that enhance the gripping characteristics of scope 2. For example, in FIG. 1A, the optional handle 18 includes a knurled surface 20.

  The flexibility or rigidity of the various sections of the shaft assembly 12 may be different or uniform. For example, the proximal shaft section 14 and handle 18 of FIGS. 1A and 1B may be rigid and may comprise a material such as stainless steel, while the distal shaft section 16 is made of a flexible material such as polyimide. Can be included. In embodiments where the shaft assembly has a flexible distal region, the scope may be inserted into a steerable instrument or other bendable instrument to allow visualization along a non-linear axis. In some embodiments, the proximal housing or shaft assembly can include one or more connectors or interfaces for coupling the scope to other instruments, such as a multi-lumen cannula. These interfaces may include, for example, any of a variety of threaded interfaces or releasable lock interfaces. The shaft assembly 12 includes at least one, if not multiple, optical fibers to transmit optical information from the distal end 6 of the scope 2 to the proximal housing 4 and, optionally, optical One or more illumination fibers can be provided to transmit the signal to the distal end 6. In other embodiments, the illumination light source may be provided at the distal end along with electrical wires or electrical wiring provided to power the illumination light source. The distal shaft section 16 can also optionally include one or more lenses that may be used to focus the image and / or illumination. The specific arrangement of the visualization fiber, the optional illumination fiber, and the optional lens may be different and can affect the viewing angle 22 of the scope 2. In some embodiments, the viewing angle of the scope may range from about 10 degrees to about 180 degrees, or from about 45 degrees to about 135 degrees, in other cases from about 90 degrees to about 120 degrees. The viewing angle 20 shown schematically in FIG. 1A is shown as being symmetrically aimed with respect to the longitudinal axis of the scope 2, but in other embodiments, the viewing angle is It may be offset from 16 vertical axes.

  Other scopes that may be used are the scopes disclosed in US Pat. Nos. 4,807,597 and 4,899,732, which are hereby incorporated by reference in their entirety. And various scopes manufactured by Vision-Sciences (Rangeburg, NY). In other embodiments, the visualization instrument includes, for example, an ultrasound imaging device that can be inserted into the body using a minimally invasive procedure, such as an intravascular ultrasound system used to visualize vascular plaques and the biliary system. Different local visualization systems can be provided.

  The scope 2 of FIGS. 1A and 1B may be inserted into an access system configured with one or more areas that allow viewing around the cutting or puncture structure used to form the access path. Good. In FIGS. 1A-1C, for example, the access system can include a tubular penetrating member 30 having a distal piercing tip 32 and at least one inner lumen 34 configured to receive the scope 2. In some alternative embodiments, one or more subcomponents of the scope may be integrated into the tubular penetrating member or provided in a separate device that is inserted into a different lumen. . For example, in some embodiments, the scope may not have an illumination fiber, instead the illumination fiber may be provided in the tubular penetrating member with the illumination connector. In this particular embodiment, providing illumination from a different location other than the distal scope can improve visibility of the tissue around the distal piercing tip or other region of the tubular penetrating member. In some further embodiments, the tubular penetrating member and the scope may be integrally formed. In still other embodiments, the scope and / or tubular penetrating member can comprise one or more additional lumens that may be used, for example, for irrigation, treatment, staining, or contrast agent delivery. .

  The inner lumen 34 of the tubular penetrating member 30 can include one or more side holes 36 and 38 to allow visualization of the surroundings from the lumen 34. In this particular example, side holes 36 and 38 are not covered, but in other embodiments disclosed herein, one or more holes may be covered with a transparent material. As shown in FIGS. 1B and 1C, the inner lumen 34 and the side holes 36 and 38 are provided so that the distal section 16 and / or the distal end 6 of the scope 2 is at least one of the side holes 36 and 38. It may be configured to protrude from. In this particular embodiment, the side holes 36 and 38 have an elliptical configuration in which their longer dimension is oriented along the longitudinal axis of the tubular penetrating member 30. The lateral holes can have a length that can range from about 0.4 mm to about 10 mm or more, sometimes from about 0.6 mm to about 3 mm, and in other cases from about 0.8 mm to about 2 mm. The holes 36 and 38 can have a width of about 0.4 mm to about 1.5 mm or more, sometimes about 0.6 mm to about 1.2 mm, and in other cases about 0.7 mm to about 0.9 mm. Although the side holes 36 and 38 are shown spaced approximately symmetrically about 180 degrees along the circumference of the tubular penetrating member 30 and aligned longitudinally, the holes are asymmetric around the circumference. The holes may be spaced apart and a number of holes may be provided aligned or misaligned along the longitudinal length. The distance between the most distal side hole and the distal point 40 of the puncture tip 32 is from about 0.5 mm to about 20 mm or more, sometimes from about 0.8 mm to about 5 mm, in other cases from about 0.8 mm It may be in the range of about 2 mm.

  Referring to FIG. 2C, the proximal portion 44 of the tubular penetrating member 30 comprises only the proximal bore 46 of the inner lumen 34, although in other embodiments the proximal portion is optionally a handle, a housing. Or some other configuration can be provided. In some specific embodiments, the proximal lumen of the inner lumen can have a flared configuration to facilitate insertion into the tubular penetrating member of the scope 2. However, in other embodiments, the scope may be inserted into the tubular penetrating member during manufacture and no configuration is provided to facilitate insertion.

  As described above, in some embodiments, the side holes may be covered with a transparent material. For example, in FIG. 3, the tubular penetrating member 50 has a hole 52 covered with a transparent window 54. The transparent window material may be an optically transparent material including, for example, various forms of glass, nylon, Pebax, PET, FEP, PTFE, polyolefin, acrylic, polycarbonate, or polyethylene. In other embodiments where the visualization instrument is a non-optical device (eg, ultrasound), the transparent window may be transmissive for certain image modalities, but not otherwise transmissive. Good.

  The distal piercing tip 32 shown in FIGS. 2A-2C has a conical configuration and a centrally located distal point 40, but in other embodiments, the distal piercing tip is an ubiquitous distal point, multiple distal points It can have a point or non-conical configuration. The distal point 40 may be sharp or meet or blunt. Also, the angle 42 of the distal puncture tip 32 may be different, for example, in the range of about 10 degrees to about 175 degrees, sometimes about 35 degrees to about 120 degrees, and in other cases about 45 degrees to about 90 degrees. May be.

  For example, in FIG. 4, the tubular penetrating member 60 comprises a distal piercing tip 62 having a cone configuration that includes one or more edges 64, 66, and 68. In this example, edges 64, 66, and 68 are linear and span the distance from distal point 70 to base 72 of distal piercing tip 62. Each of the edges 64, 66, and 68 may be sharp or blunt. In other embodiments, the edge may extend less than the entire length of the distal piercing tip and may have a non-linear configuration. Some non-linear configurations can include, for example, helical configurations, angular configurations, and concentric configurations. As further shown in FIG. 4, the tubular penetrating member 60 includes a distal viewing region 74 that is a number of rectangular holes 76 separated by struts 78 connecting the distal shaft section 80 with the distal piercing tip 62. FIG. 5 shows another embodiment of a tubular piercing member 90 where the viewing region 92 comprises a transparent tube 94 or cylinder connecting the distal shaft section 96 with the distal piercing tip 98. The distal piercing tip 98 also includes a transparent material.

  FIGS. 6A and 6B illustrate another embodiment of a tubular penetrating member 200 comprising a distal viewing region 202 having one or more lateral holes 204 and 206 with a distal piercing tip 208 having a protruding blade 210 or other piercing configuration. The embodiment of is shown. Although a single blade is shown in FIGS. 6A and 6B, multiple blades may be provided in other embodiments. The blade 210 may also have a triangular configuration as shown, but may have other configurations such as a spade configuration, a square or circular spatula configuration, or any of a variety of other blade configurations. Can do. The orientation of the blade relative to the distal viewing region or hole can also be different. For example, in FIGS. 6A and 6B, a single blade 210 is located in a plane that exists symmetrically in the center of each hole 204 and 206, but in other embodiments, the blade exists symmetrically between the holes. Or a plane offset or inclined with respect to the central longitudinal axis of the tubular penetrating member.

  As described above, some embodiments of the penetrating member may comprise a multi-lumen configuration. For example, in FIGS. 7A and 7B, penetrating member 220 comprises a scope lumen 222 for inserting a fiber optic scope. Scope lumen 222 may be used to provide visualization through transparent piercing tip 224 of penetrating member 220. The penetrating member can also include an auxiliary lumen 226 that can be used for any of a variety of functions. In the particular configuration of FIGS. 7A and 7B, the auxiliary lumen 226 has a distal lumen 230 that extends through the transparent piercing tip 224. The transparent piercing tip 224 of this example comprises a gradient configuration that provides a large flat surface 228. In some cases, the large plane 228 may improve visibility through a transparent material compared to multiple small ramps. Typically, the scope lumen 222 has a linear configuration that is not perpendicular to the large plane 228, but in some embodiments the scope lumen is relative to the large plane 228 or any other viewing surface. An angle close to a right angle may be used.

  The penetrating member 220 of FIGS. 7A and 7B further comprises an optional balloon 232. The balloon 232 can be joined to the shaft 234 of the penetrating member 220 to form a balloon cavity 236 that can be inflated by the inflation lumen 238 of the shaft 234 at the inflation hole 240. Balloon 232 may be inflated with a liquid such as gas or saline. In some cases, the balloon 232 may be used during an access procedure to expand the access path to push away the tissue surrounding the penetrating member 220 so that the tissue is visualized and identified. And the path can be expanded to allow larger instruments to pass through.

  Balloon 232 can comprise any of a variety of stretchable and non-stretchable medical balloon materials including, but not limited to, polyurethane or PET, for example. Balloon assembly 230 can have any of a variety of inflated configurations including, but not limited to, for example, cylindrical, conical, spherical, elliptical, tapered, or stepped configurations. The balloon 232 of FIG. 7B has an expanded donut shape that is symmetrically arranged around the circumference of the shaft 234, but in other embodiments the shape of the balloon may be offset with respect to the axis. Or may be arranged eccentrically. When in an uninflated state, the balloon 232 can have an outer diameter of about 4 mm or less, sometimes about 3.6 mm or less, and in other cases about 3 mm or less. When in an inflated state, the balloon 232 can have a maximum outer diameter of about 4 mm or more, sometimes about 5 mm or more, and in other cases about 6 mm or more. The longitudinal length of balloon 232 attached to shaft 234 may range, for example, from about 3 mm to about 20 mm, sometimes from about 4 mm to about 10 mm, and in other cases from 5 mm to about 8 mm.

  Balloon 232 may be attached to shaft 234 by, for example, adhesive or thermal bonding. In some embodiments, an attachment structure or process that improves the sealing between the balloon and the tubular shaft may be used to support the use of higher inflation pressures without separating the balloon from the tubular shaft. Good. For example, crimping or heat shrink tubing may be used to enhance the joining or attachment process. Crimping or heat shrink tubing may be applied primarily to facilitate setting up other joining processes. In other embodiments, a crimp ring or heat shrink tube may be incorporated into the final assembled product.

  In some embodiments, the lateral holes of the penetrating member may be configured such that visualization occurs through the balloon and balloon cavity. This allows the user to selectively adjust the distance to any adjacent tissue by selectively inflating or uninflating the balloon. For example, in FIG. 8, penetrating member 250 includes a distal blade 252 and a viewing region 254 that includes two side holes 256 and 258. Side holes 256 and 258 are in communication with balloon cavity 260 of balloon 262 sealed around holes 256 and 258. Here, the inner lumen 264 of the penetrating member 250 is configured to receive a scope, but is also configured to inflate and deflate the balloon cavity 260. The scope used with this particular penetrating member 250 can be configured to withstand the pressure at which the balloon 262 can be inflated. FIG. 9 shows another embodiment of a penetrating member 270 comprising a conical penetrating tip 272, a transparent inflatable balloon 274, and a transparent shaft 276. In some cases, the transparent shaft can allow visualization of tissue and structure along the entire access path, not just the region around the distal end of penetrating member 270.

  FIGS. 10A and 10B are general and detailed views of one embodiment of a balloon penetrating member 300 comprising a tubular shaft 302 that includes a proximal end 304 and a distal end 306. The proximal end 304 of the penetrating member 300 is attached to an optional housing 318 and the distal end 306 includes an inflatable balloon 316 and a penetrating tip 317. The various ports 308, 310, 312 and 314 may optionally be provided on an axis or on an optional housing 318, including but not limited to fluid / material infusion / drainage / aspiration. Any of a variety of uses, including insertion / removal / support of an endoscope or fiber optic device, inflation / deflation of an inflatable balloon 316, and insertion / removal or support of other instruments or tools May be configured for. The housing 318 may also include an optional steering mechanism 320.

  The steering mechanism 320 may be configured to bend the shaft 302 at one or more bend regions 324. In FIG. 10C, the steering mechanism 320 is shown with a portion of the port tube and housing 318 removed. The steering mechanism 320 includes a lever 322 that is configured to rotate or pivot on a lever axle 390. In other embodiments, the steering mechanism 320 may comprise a slide, knob, or other configuration. The lever 322 is attached to two control members 392 that are slidably positioned along the length of the shaft 302 and attached to a distal position of the shaft 302. Actuation of the lever 322 may increase the range and force of movement by one or more biasing members 398. The biasing member 198 can comprise a helical spring as shown in FIG. 10C, but can also comprise a leaf spring or any other type of biasing member configuration. The range of motion of the lever 322 can also be affected by the size and / or configuration of the lever hole 399 provided in the housing 318. In some embodiments, an optional locking mechanism may be provided to maintain the lever in substantially one or more positions.

  The control member 392 can comprise a wire, thread, ribbon, or other elongated structure. The flexibility and / or rigidity of the control member 392 may vary depending on the particular steering mechanism. In further embodiments, the characteristics of the control member 392 may vary along its length. In embodiments comprising two or more control members, the control members are configured symmetrically (eg, having the same length, cross-sectional area or cross-sectional shape, or attachment site opposite the longitudinal axis of the tubular shaft, etc.) No need. Also, the individual control members need not have the same configuration along their length.

  The bending range of the bending region 324 can be different. The balloon penetrating member 300 may be configured to have a bending range on one side or both sides with respect to an intermediate position of the shaft. The bending range is from about 0 degrees to about 135 degrees, sometimes from about 0 degrees to about 90 degrees, in other cases from about 0 degrees to about 45 degrees, and in other cases from about 0 degrees to about 15 degrees to about 20 degrees It may be a range. The bending range on the other side, if any, may be less than, equal to, or greater than the first side.

  As previously, penetrating members with direct visualization capabilities may be used for various medical procedures in various fields. A scoped penetrating member is used to provide initial access to a specific target site that would otherwise be done blindly, under fluoroscopy, or using an external image modality. May be. In one particular example, the penetrating member may be used to provide access to the epidural or paravertebral region of the cervical, thoracic, or lumbar spine. Once access to the area is achieved, perform various spinal procedures including, for example, adhesive dissolution, anesthesia injection, nucleotomy, discectomy and foramen dilation, and laminectomy Therefore, an endoscopic instrument may be arranged using the access path. Some examples are described below.

  11 to 13 are schematic views of the lumbar region 100 of the spine. The spinal canal 102 is formed by a plurality of vertebrae 104, 106, and 108, with the vertebral bodies 110, 112, and 114 in the anterior and vertebral arches 116 and 118 in the posterior. The vertebra of the superior vertebra 104 and the adjacent connective tissue have been omitted in FIG. 11 to better illustrate the spinal cord 122 within the spinal canal 102. The spinal nerve 124 branches bilaterally from the spinal column 122 and exits the spinal canal 102 through an intervertebral hole 126 (best seen in FIGS. 12 and 13) formed by adjacent vertebrae 104, 106, and 108. The intervertebral hole 126 is typically bounded by the lower surface of the pedicle 120, a portion of the vertebral bodies 104, 106, and 108, the lower articular process 128 of the adjacent vertebra, and the upper articular process 130. Also projecting from vertebral arches 116 and 118 are transverse processes 132 and posterior spinous processes 134 of vertebrae 106 and 108. Located between vertebral bodies 110, 112, and 114 is an intervertebral disc 132.

  Referring to FIG. 12, the spinal cord 122 is covered by a capsular sac 136. The space between the pericardial sac 136 and the spinal canal 102 boundary is known as the epidural space 138. Epidural space 138 is bounded anteriorly and posteriorly by longitudinal ligament 140 and yellow ligament 142 of spinal canal 102 and laterally bounded by pedicle 120 and intervertebral foramina 126 of vertebrae 116 and 118, respectively. . The epidural space 138 continues with the paravertebral space 144 through the intervertebral foramina 126.

  This anatomical structure allows a number of exemplary access procedures to be performed. The particular access procedure may depend on the suspected diagnosis and / or treatment that may be performed. For example, FIGS. 14A and 14B use a penetrating member 500 that forms an access path between adjacent vertebrae 502 and 504 that may be used to access the center of the patient's spinal canal and the epidural space. 1 schematically shows an access procedure from the midline of the spine. Such procedures have been used, for example, to provide epidural anesthesia, but inaccurate needle placement has caused anesthesia intravascular injection or other damage.

  To perform an epidural access procedure using a penetrating member with direct visualization, the patient is placed in a sitting or recumbent position with the spinal column bent forward. Marks on the surface or other indicia are used to identify target levels along the spine, prepare the skin, and cover. Local anesthesia is performed on the skin area. The scoped penetrating member 500 is inserted into the skin tissue 506 until the ligament tissue of the interspinous ligament is visualized and monitored until the tip of the penetrating member 500 exits through the front surface of the ligament and enters the epidural space 508. . In some embodiments, the scope may be removed from the penetrating member 500 while maintaining the penetrating member 500 in place, and a guidewire may be inserted through the penetrating member and into the epidural space. . The penetrating member 500 may then be removed, and optionally a dilator may be inserted and pulled over the guide wire. Then, optionally, an introducer is placed over the guide wire, and then the guide wire is optionally removed. An endoscope or other tubular instrument with a miniscope or fiberscope is then inserted through the introducer and / or over the guide wire to re-visualize the epidural space. In some cases, a miniscope or fiberscope drawn from the penetrating member may be inserted into an endoscope or tubular instrument to provide visualization.

  In another procedure, using direct visualization, access to the intervertebral foramen is achieved using a penetrating member. This procedure places the patient in a prone position. Identify the target site, prepare the skin, and cover. Referring to FIGS. 15A and 15B, anesthesia is performed at a position approximately 10 cm from the midline, and a scoped penetrating member 520 is inserted into the skin tissue 522. The penetrating member 520 may be tilted into the skin tissue 522 to an angle of about 35 degrees relative to the median sagittal plane, or at least partially penetrates the skin tissue 522 and then steers toward the midline. May be. After partially penetrating the skin tissue, the penetrating member 520 is midlined to avoid interference from the spinous process 524 of the vertebra 526 and / or to achieve a specific access angle when reaching the target site. Steer towards. As penetrating tip 524 punctures intact body tissue, tissue surrounding piercing tip 528 of penetrating member 520 is visualized and penetrating tip 524 exits the body tissue and enters paravertebral space 530 adjacent to hole 532. Can be seen. To avoid inadvertently damaging the nerves present in the intervertebral foramen, insertion of the penetrating member is stopped at that point and the penetrating member 520 is replaced with another therapeutic or diagnostic instrument.

  The penetrating member described herein may be used in any of a variety of access procedures. In some embodiments, the penetrating member may be inserted through the chest wall, and visualization is used to determine when the pleural effusion that accumulates in the pleural cavity is full, thereby developing lung rupture and pneumothorax Reduce the risk of In another example, the penetrating member may be inserted through the abdominal wall and visualization is used to determine when it reaches the abdominal cavity, thereby risking perforation of other abdominal organs such as the liver or intestine. Reduce.

  In addition to reducing the risk of inadvertently puncturing or damaging adjacent tissue, penetrating members with direct visualization capabilities are judged by indirect or external imaging, tactile response, or other proxy means May be used to identify various body structures that may be difficult. For example, patients with reduced body fluid volume due to blood loss or dehydration, or initially achieved access, but further insertion of an access device opens a hole through the distal luminal surface and disengages from the target site For many reasons, such as when it occurs, or when making an incision along the wall of an artery, venous and arterial access can be difficult. For example, in FIG. 16, a scoped penetrating member 540 is inserted into the patient's groin region to achieve femoral artery access. The piercing tip 542 of the penetrating member 540 is inserted through the skin layers 544 and 546 and then through the underlying connective tissue 548. When the penetrating member 540 is inserted, the tissue surrounding the puncture tip 542 is visualized to avoid missing a blood flush indicating that it has entered the artery 550 and at the same time whether the femoral vein has been accessed, or the penetrating member Also check whether 540 has passed to any adjacent structure. If this happens, the penetrating member 540 can be partially pulled out and redirected towards the target site based on the markings visualized from the penetrating member 540.

  It should be understood that the present invention is not limited to a particular exemplary embodiment, and can of course vary. Also, the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting because the scope of the present invention is limited only by the appended claims. I want you to understand that.

  Where a range of values is provided, each value intervening between the upper and lower limits of the range, that is, up to one-tenth of the lower limit unit, unless specifically stated otherwise in context It should be understood that it is disclosed. Each smaller range between any stated or intervening value in the stated range and any other stated or intervening value in that range is encompassed within the invention. . The upper and lower limits of these smaller ranges may independently be included or excluded from that range, and one or both limits may be included in the smaller range, or both Each range not included in a range is also encompassed by the present invention, subject to any specifically excluded limits of the described range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the invention.

  Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, here are some potential and suitable methods and materials It explains about. All publications mentioned in this specification are herein incorporated by reference to disclose and explain the methods and / or materials associated with the citation of the publication. In the case of conflict, it is to be understood that this disclosure supersedes any disclosure of incorporated publications.

  It should be noted that as used in this specification and the appended claims, the singular forms include the plural referents unless the context clearly indicates otherwise. Thus, for example, reference to “a blade” includes a plurality of such blades, and reference to “an energy source” includes one or more energy sources and equivalents known to those skilled in the art, and the like. Includes mention.

  The publications discussed herein are provided solely for their disclosure. Nothing in this specification should be construed as an admission that the invention is not entitled to antedate such publication by prior invention. Furthermore, if the dates of publication provided are present, this may be different from the actual publication date and may need to be individually confirmed.

  The foregoing is merely illustrative of the principles of the invention. Those skilled in the art will understand that although not explicitly described or shown herein, the principles of the invention may be embodied and various arrangements may be devised which fall within the spirit and scope thereof. I want to be. In addition, all examples and conditional language listed herein are intended primarily to assist the reader in understanding the principles of the invention and the concepts that the inventors have contributed to promoting the art. And should not be construed as limited to such specific examples and conditions. Furthermore, all statements of principles, aspects, and embodiments of the invention, and specific examples thereof, are intended to encompass both their structural and functional equivalents. Also, such equivalents are intended to include both presently known equivalents and future developed equivalents, ie, any element that performs the same function regardless of structure. Accordingly, it is not intended that the scope of the invention be limited to the exemplary embodiments shown and described herein. Rather, the scope and spirit of the invention is embodied by the appended claims. For all embodiments described herein, the method need not be performed continuously.

  The following are claimed as new and as desired to be protected by US Patent.

Claims (40)

A system for accessing a patient's epidural space,
A first flexible fiberscope removably positioned within a longitudinal lumen of a rigid tubular member, the rigid tubular member being at least one located proximal of the distal penetrating tip and the distal penetrating tip A first flexible fiberscope having two viewing openings;
The distal penetrating tip is configured to penetrate the intact body tissue and form a tissue pathway through the intact body tissue and toward the patient's epidural space;
The first flexible fiberscope is configured to visualize the tissue path while the distal penetrating tip forms at least a portion of the tissue path;
The system
A dilator configured to be passed and pulled over the rigid tubular member;
An introducer configured to be inserted over the rigid tubular member, wherein the rigid tubular member is configured to be removed from the introducer;
A second flexible fiberscope configured to be inserted into the steerable multi-lumen cannula;
The steerable multi-lumen cannula is configured to be inserted through the introducer;
The system wherein the second flexible fiberscope is configured to visualize the epidural space.   The system of claim 1, wherein the first flexible fiberscope and the second flexible fiberscope are the same fiberscope.   The second flexible fiberscope is configured to be inserted into the steerable multi-lumen cannula before the steerable multi-lumen cannula is inserted through the introducer; The system of claim 1.   The system of claim 1, wherein the first flexible fiberscope is rotatable within the lumen of the rigid tubular member.   The system of claim 1, wherein the distal penetrating tip is configured to be reoriented to adjust the formation of the pathway toward the spinal region.   The system of claim 1, wherein the second flexible fiberscope is configured to visualize the tissue path during insertion of the steerable multi-lumen cannula through the introducer. .   The second flexible fiberscope is configured to visualize the tissue path through a wall of the introducer, at least a portion of the wall comprising an optically transparent material. The system described in.   The system of claim 1, wherein the first flexible fiberscope is insertable into the rigid tubular member.   The system of claim 1, wherein the first flexible fiberscope is configured to visualize the tissue pathway through an optically transparent structure located in a viewing opening. A system for accessing a patient's body area,
A piercing member for piercing the patient's unpunctured body tissue comprising an illumination assembly and a direct visualization assembly;
The puncture member is configured to form a tissue path through an unpunctured body tissue;
The direct visualization assembly is configured to visualize the tissue pathway while at least a portion of the tissue pathway is formed through the unpunctured body tissue.   The system of claim 10, wherein the piercing member is a graded piercing member.   11. The system of claim 10, further comprising a steering controller for the piercing member, the steering controller being operable to form a non-linear tissue path.   The system of claim 10, wherein the puncture member is configured to allow fluid to flow through the puncture member. 11. The system of claim 10, further comprising x-ray examination positioning means for confirming the position of a distal tip that penetrates the tissue by x-ray examination. The illumination assembly and the direct visualization assembly are removable from the piercing member;
The system
A first guide element configured to be passed through the patient using the piercing member;
The system of claim 10, wherein the first guide element is configured to remain in one position when the piercing member is removed from the patient.   16. The illumination assembly and the direct visualization assembly are removable from the piercing member by removing a fiberscope in which the illumination assembly and the direct visualization assembly are integrally formed. The system described in.   16. The system of claim 15, wherein the first guide element is a guide wire that is insertable into the patient through the piercing member.   And a second guide element configured to be passed through the patient using the first guide element, the first guide element comprising the first guide element. The system of claim 15, wherein the system is removable from the two guide elements. The direct visualization assembly is insertable into a luminal member;
The system of claim 16, wherein the luminal member is insertable into the patient. A system for performing an access procedure,
A miniscope,
A video connector located around the proximal end;
A lens located around the distal end;
A flexible axial section comprising at least one illumination optical fiber and at least one viewing optical fiber, and having a longitudinal length of at least about 3 inches and an average axial cross-sectional area of less than about 1.2 mm ² . With a miniscope,
An elongated puncture member,
A distal penetrating tip;
A miniscope receiving opening;
An axial section located between the distal penetrating tip and the miniscope receiving opening, the axial section comprising a miniscope lumen in communication with the proximal miniscope receiving opening, and at least about A puncture member comprising: an axial section having a longitudinal length of 3 inches and an average axial lumen cross-sectional area of less than about 1.3 mm ² and comprising at least one distal viewing window.   21. The system of claim 20, wherein the miniscope is pre-inserted into the elongate piercing member.   21. The system of claim 20, wherein the distal penetrating tip comprises a conical configuration.   21. The system of claim 20, wherein the distal penetrating tip comprises at least one cutting blade.   21. The system of claim 20, wherein the distal penetrating tip comprises a flat blade structure.   21. The system of claim 20, wherein the at least one viewing window comprises a viewing opening.   21. The system of claim 20, wherein the at least one viewing window comprises an optically transparent material.   21. The system of claim 20, wherein the distal penetrating tip comprises an optically transparent material.   21. The system of claim 20, wherein the axial segment of the elongate piercing member is a multi-lumen axial segment.   30. The system of claim 28, wherein the multi-lumen shaft comprises at least one fluid lumen.   30. The system of claim 28, wherein the multi-lumen shaft comprises an expandable member connected to the multi-lumen shaft.   32. The system of claim 30, wherein the expandable member comprises a balloon member.   32. The system of claim 31, wherein the multi-lumen shaft further comprises a balloon inflation lumen.   21. The system of claim 20, wherein at least one viewing window is located at a distal end of the miniscope lumen.   21. The system of claim 20, wherein at least one viewing window is located on a sidewall of the miniscope lumen.   21. The system of claim 20, wherein the elongate piercing member comprises at least two viewing windows.   36. The system of claim 35, wherein at least two viewing windows are sequentially disposed along a longitudinal length of the miniscope lumen.   36. The system of claim 35, wherein at least two viewing windows are sequentially arranged in parallel along a longitudinal length of the miniscope lumen.   21. The system of claim 20, wherein the elongate piercing member further comprises a flexible compartment.   40. The system of claim 38, wherein the elongate piercing member further comprises a steering assembly configured to bend the flexible section.   The system of claim 1, wherein the penetrating tip comprises a single blade.

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